FDA Cracks Down on Websites Selling Unapproved Drugs

The FDA undertook action last week against more than 4,000 internet pharmacies, charging the pharmacies as illegally selling potentially dangerous and unapproved drugs to consumers. The FDA’s actions included both civil and criminal charges, seizure of illegal products, and removal of offending websites.

As part of a collaborative effort with law enforcement and customs and regulatory authorities from 100 countries in Operation Pangea V, over 18,000 illegal pharmacy websites were shutdown between September 25 and October 2. The operation also netted about $10.5 million worth of pharmaceuticals around the world. In many cases, the medicines contain active ingredients that are approved by FDA for use only under the supervision of a licensed health care practitioner or active ingredients that were previously withdrawn from U.S. market due to safety issues.

The goal of the annual operation was to combat the online sale and distribution of potentially counterfeit and illegal medical products by identifying producers and distributors of illegal pharmaceutical products and medical devices and remove these products from the supply chain.

In late September, the FDA reinforced its online efforts with the launch of a national campaign to educate Americans about the risks of buying prescription medications over the Internet. BeSafeRx seeks to raise public awareness about the health risks of using fraudulent internet pharmacies and what consumers can do to protect themselves.

The agency identified a few of the following medicines as illegally marketed:

domperidone; removed from the United States market in 1998 because of serious adverse effects, including irregular heartbeat, stopping of the heart, or sudden death. Domperidone has been targeted in an unapproved manner to breastfeeding women trying to increase milk production;

isotretinoin; marketed as Accutane in the U.S., the product is used to treat severe nodular acne and carries significant potential risks, including severe birth defects if pregnancy occurs while using this medicine;

Tamiflu; used to treat the flu, is sold online in a “generic” version. However, the FDA has not approved of any generic version and the agency noted that the fraudulent versions of “generic Tamiflu” online contained the wrong active ingredients, which could cause severe allergic reactions in a subset of the population; and

Viagra; used to treat erectile dysfunction, but should not be used by consumers with certain heart conditions.

The FDA sent Warning Letters to the operators of the identified websites. As a follow-up, the agency also sent notices to domain name registrars and internet service providers informing these services that the websites were selling products in violation of U.S. law.